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Tislelizumab for Liver Cancer

Phase 2

Recruiting

Led By Salma Jabbour, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrate adequate bone marrow and organ function as defined below: Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL; Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN; Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours; Hepatic - Serum total bilirubin ≤ 3 mg/dL, AST (SGOT) and ALT (SGPT) ≤ 5x ULN, Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose

Age ≥ 18 years

Must not have

Any of the following cardiovascular risk factors: a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug

Direct tumor extension into the stomach, duodenum, small bowel or large bowel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding the drug Tislelizumab to standard treatment for inoperable HCC will improve one year progression-free survival rates and control of the disease.

Who is the study for?

This trial is for adults with advanced inoperable liver cancer (HCC) who haven't had systemic therapy but may have had TACE. They should be treatment-ready, without severe liver impairment (Child-Pugh A or B7), and no spread of cancer outside the liver. Participants need good organ function, manageable pain levels, a life expectancy over six months, and must agree to use effective birth control.

What is being tested?

The study tests if Tislelizumab can improve survival rates when given after local treatments like radiation for HCC. It aims to see if this drug helps control the disease locally and fights off tiny undetected spreads of cancer.

What are the potential side effects?

Tislelizumab might cause immune-related side effects such as inflammation in various organs, potential skin reactions, fatigue, possible hormonal imbalances due to thyroid issues or diabetes management changes if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have liver cancer, haven't had systemic treatment but may have had TACE.

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I am able to get out of my bed or chair and move around.

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My liver cancer diagnosis was confirmed by specific tests or imaging.

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My liver is functioning well enough, but I can't have liver surgery or a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had recent serious heart or stroke issues.

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My cancer has spread to my stomach or intestines.

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I have had Yttrium therapy for liver cancer.

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My liver cancer affects the main bile ducts.

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I've had radiation to my liver that might risk harming healthy tissue if repeated.

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I need a procedure to manage fluid buildup in my abdomen.

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My cancer has spread outside the liver with tumors larger than 3.0 cm in total.

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I am not currently fighting a severe infection requiring strong antibiotics or antivirals.

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I haven't had severe infections or been hospitalized for them in the last 4 weeks.

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I have received immunotherapy before.

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My liver cancer has spread to more than five areas or is affecting my portal vein.

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I have had a liver transplant.

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My diabetes is not under control, or I have significant blood mineral imbalances.

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I have an immune system disorder that needs ongoing treatment.

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I have hepatitis B with a low viral load and am on treatment, but I don't have hepatitis C.

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I have a history of lung conditions like fibrosis or pneumonitis.

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I have Type 1 diabetes managed with a stable insulin routine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety as assessed by number of participants experiencing adverse events

Secondary study objectives

Response and progression will be evaluated in this trial using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (v1.1).

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843

31%

Anaemia

24%

Weight decreased

17%

Cough

16%

Constipation

16%

Decreased appetite

16%

Pyrexia

15%

Nausea

15%

Aspartate aminotransferase increased

14%

Hypoalbuminaemia

13%

Diarrhoea

13%

Alanine aminotransferase increased

13%

Fatigue

12%

Hyponatraemia

12%

Hypothyroidism

11%

Vomiting

11%

Asthenia

11%

Pneumonia

11%

Back pain

10%

Dyspnoea

10%

Pruritus

Dysphagia

Arthralgia

Hypokalaemia

Rash

Insomnia

Hyperglycaemia

Blood alkaline phosphatase increased

Productive cough

Abdominal pain

Malaise

Hypoproteinaemia

Gastrooesophageal reflux disease

White blood cell count increased

Lymphocyte count decreased

Gamma-glutamyltransferase increased

Platelet count decreased

Hypertension

Dizziness

Stomatitis

Blood bilirubin increased

Cancer pain

Hypotension

Oedema peripheral

Pneumonitis

Leukopenia

Haemoptysis

Abdominal pain upper

Abdominal distension

Nasopharyngitis

White blood cell count decreased

Blood creatine phosphokinase MB increased

Blood creatine phosphokinase increased

Upper respiratory tract infection

Myalgia

Hypoglycaemia

Hyperthyroidism

Hyperkalaemia

Hypocalcaemia

Dysphonia

C-reactive protein increased

Hypochloraemia

Hyperuricaemia

Neutrophil count decreased

Thrombocytopenia

Oesophageal obstruction

Upper gastrointestinal haemorrhage

Pneumonia aspiration

Pulmonary haemorrhage

Pleural effusion

Oesophagomediastinal fistula

Oesophageal stenosis

Hypercalcaemia

Neutropenia

Death

Oesophageal fistula

Tumour pain

Multiple organ dysfunction syndrome

Peripheral sensory neuropathy

Immune-mediated lung disease

General physical health deterioration

Immune-mediated myositis

Pulmonary embolism

Sepsis

Type 1 diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

Tislelizumab

Investigator Chosen Chemotherapy (ICC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tislelizumab in conjunction with radiation therapyExperimental Treatment1 Intervention

Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment. Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy. Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4700

0 / 23Eligibility criteria met